BIMEKIZUMAB for Axial spondyloarthritis | Psoriasis

Inclusion criteria

• {"criterion_text":"- •\tFemale or male adult-patients aged between 18 and ≤ 60 years\n- •\tHistory of inadequate response to at least 2 NSAIDs at a therapeutic dose range for >= 2 weeks each or intolerance to >= 2 NSAIDs for at least 3 months\n- •\tPatient with active disease defined by ASDAS-CRP ≥ 2,1\n- •\tPatient with spontaneous pain of the ACW ≥ 4/10 on NS\n- •\tPatient with tenderness at the pressure of at least one of the four chondro-sternal joints of enthesitis MASES score\n- •\tStable dose of ongoing drug prescriptions (analgesics, NSAIDs) during the last month\n- •\tPatient with at least one unequivocal inflammatory lesion of the ACW highlighted by MRI and/or ultrasonography and/or scintigraphy and/or CT scan < 6 months at the time of randomization, validated by the investigator of each center (no central reading for inclusion procedure)\n- •\tPatient having read and understood the information letter and signed the consent form\n- •\tPatient affiliated with, or beneficiary of a social security (health insurance) category\n- •\tWomen of childbearing potential (in accordance with CTCG recommendations, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): -\twith effective contraception (Cf. CTCG recommendations) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during treatment and for 5 months after cessation of ADA and BKZ treatments and, -\t a negative blood pregnancy test by b-HCG at inclusion\n- •\tWomen permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)\n- •\tPostmenopausal women: In accordance with CTCG recommendations, a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n- •\tPatient having an established diagnosis by a rheumatologist of axial or predominantly axial SpA with or without psoriasis fulfilling the 2009 ASAS classification criteria\n- •\tSpA evolving > 3 months\n- •\tbDMARD and JAKi naïve"}

Exclusion criteria

• {"criterion_text":"- Pregnant woman;\n- One of the pre-biotherapy assessment not respected (viral serology, oral health consultation, evaluation of active or inactive (“latent”) tuberculosis infection, …).\n- Patient with contraindication to BIMZELX® 160 mg, solution for injection in pre-filled syringe or pre-filled pen : \t-Hypersensitivity to the active substance or to any of the excipients, \t-Clinically important active infections (e.g. active tuberculosis)\n- Patient with contraindication to adalimumab (HUMIRA or one of its biosimilars (AMGEVITA, IMRALDI, HULIO, IDACIO, YUFLYMA, AMSPARITY, HYRIMOZ, HUKYNDRA) : \t-Hypersensitivity to the active substance or to any of the excipients, \t-Active tuberculosis or other severe infections such as sepsis and opportunistic infections, \t-Moderate to severe heart failure (NYHA classes III/IV).\n- Patient with a contraindication to performing MRI in centers performing MRI for the study\n- Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision\n- Patient participating or having participated in a therapeutic drug trial in the 3 months prior to inclusion\n- Woman of childbearing potential not using contraception;\n- Patient with an history of chest trauma and/or chest surgery;\n- Patient with an history of radiotherapy in the anterior thoracic region;\n- Infiltration of a cortisone derivative performed in one or more joints of the ACW during the last 3 months\n- Satisfaction of the 2016 ACR diagnostic criteria of fibromyalgia (Appendix 9);\n- Concomitant inflammatory bowel disease (IBD) (contraindication for IL-17i use);\n- Moderate or severe plaque psoriasis requiring higher doses of ADA or BKZ;\n- Analgesic treatment with strong opioids (WHO level III) with an average daily dose > 30 mg/day of morphine (or equivalent)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)","definition_or_measurement_approach":"ASAS40 measured at the 6-month visit; ASAS40 indicates a ≥40% improvement in 3 of 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (morning stiffness)) as specified in the primary endpoint description."}

Secondary endpoints

• {"endpoint_text":"- The endpoint will be the average spontaneous ACW pain (measured on a NS) between baseline and the 6-month visit using repetitive self-evaluations of pain collected every week at different day times (dedicaded digital tool).","definition_or_measurement_approach":"Average spontaneous anterior chest wall (ACW) pain measured on a numerical scale (NS) between baseline and 6 months using repetitive self-evaluations collected weekly at different times of day via a dedicated digital tool."}

France

Earliest CTIS Part Ii Submission Date

17-02-2026

Latest Decision Or Authorization Date

03-04-2026

Processing Time Days

45

Number Of Sites

28

Number Of Participants

150

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France